BEUDAMED
    FDA Enforcement Class II Terminated

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351

    Recall: Z-2142-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2142-2018
    Event ID
    80064
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    April 30, 2018
    Classification Date
    June 11, 2018
    Termination Date
    October 4, 2019
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351

    Reason

    Five warning statements are missing from the instructions for use.

    Code Info

    All devices since release of B.05 (March 2016) prefix date code >/= US096

    Distribution

    Worldwide Distribution -- US, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.

    Quantity

    7,178